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Efficacy and Safety of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) in Advanced Heart Failure (NYHA Class III-IV) (REVIVE-HEART) Phase 3 80

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Die klinische Studie NCT07496372 (REVIVE-HEART) untersucht Behandlung im Zusammenhang mit Herzinsuffizienz. Diese interventionsstudie der Phase 3 hat den Status noch nicht rekrutierend. Der Start ist für 30. April 2026 geplant, bis 80 Teilnehmer aufgenommen werden. Durchgeführt von Help Therapeutics wird der Abschluss für 31. August 2027 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 27. März 2026 aktualisiert.
Kurzbeschreibung
The purpose of this clinical study is to evaluate the efficacy and safety of intramyocardial injection of human induced pluripotent stem cell-derived cardiomyocyte injection (HiCM-188) in patients with advanced heart failure (NYHA Class III-IV)
Ausführliche Beschreibung
REVIVE-HEART is a multicenter, randomized, controlled, confirmatory clinical trial evaluating patients with advanced heart failure (NYHA III-IV). Participants were assigned to receive either conventional coronary artery bypass grafting (CABG) alone or CABG combined with HiCM-188 (150 million cells). The cells were administered via myocardial injections around the infarcted area, followed by postoperative immunosuppre...Mehr anzeigen
Offizieller Titel

Multicenter, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Intramyocardial Injection of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) in Advanced Heart Failure (NYHA Class III-IV)

Erkrankungen
Herzinsuffizienz
Weitere Studien-IDs
  • REVIVE-HEART
  • Liu XC
NCT-Nummer
NCT07496372
Studienbeginn (tatsächlich)
2026-04-30
Zuletzt aktualisiert
2026-03-27
Studienende (vorauss.)
2027-08-31
Geplante Rekrutierung
80
Studientyp
Interventionsstudie
PHASE
Phase 3
Status
Noch nicht rekrutierend
Stichwörter
Advanced heart failure
HiCM188
HiCM-188
REVIVE-HEART
cardiomyocyte
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Einfach verblindet
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
Aktives VergleichspräparatControl group
Coronary artery bypass grafting surgery
CABG surgery
Conventional coronary artery bypass grafting (CABG) surgery
ExperimentellExperimental group
Intramyocardial Injection of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) during coronary artery bypass grafting surgery
HiCM-188 therapy
Intramyocardial Injection of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) during coronary artery bypass grafting surgery
CABG surgery
Conventional coronary artery bypass grafting (CABG) surgery
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
6-minute walk distance (6MWD)
12 months after surgery
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
All-cause mortality and cardiovascular mortality
12 months after surgery
6MWD
6 months after surgery
Change from baseline in the NYHA classification
12 months after surgery
Worsening heart failure (including events requiring hospitalization or emergency treatment due to worsening symptoms and signs of heart failure)
12 months after surgery
Change from baseline in the Minnesota Living with Heart Failure Questionnaire (MLHFQ)
The MLHFQ is a self-administered disease-specific outcome measure instrument for patients with heart failure (HF), comprising 21 items rated on Likert scales, representing different degrees of impact of HF on QoL. The MLHFQ scores are on a range of 0-105, in which lower scores reflect better health status.
12 months after surgery
Change from baseline in the SF-36 questionnaire
The 36-Item Short Form Survey(SF-36) is a self-administered outcome measure instrument that comprises 36 items grouped into 8 dimensions: limitations in physical activities because of health problems, limitations in social activities because of physical or emotional problems, limitations in usual role activities because of physical health problems, bodily pain, general mental health, limitations in usual role activities because of emotional problems, vitality, general health perceptions. The SF-36 scores are on a range of 0-100, in which higher scores reflect better health status.
12 months after surgery
Myocardial blood flow as assessed by SPECT
12 months after surgery
Myocardial viability as assessed by SPECT
12 months after surgery
Left ventricular ejection fraction as assessed by MRI
Left ventricular ejection fraction
12 months after surgery
Cardiac Volumes as assessed by MRI
Left ventricular end-diastolic volume index (LVEDVi), Left ventricular end-systolic volume index (LVESVi) and Stroke Volume (SV)
12 months after surgery
Scar size as assessed by MRI
12 months after surgery
Change from baseline in NT-proBNP level
12 months after surgery
Tumor markers abnormally elevated compared to baseline
12 months after surgery
Other AEs
12 months after surgery
Teilnahme-Assistent
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
  1. Aged 18 to 75 years, regardless of gender;
  2. Patients with ischemic heart failure with NYHA functional class III or IV after receiving the maximum tolerated dose of guideline-directed medical therapy (GDMT);
  3. LVEF ≤ 35% as measured by cardiac MRI;
  4. Coronary angiography meeting the indications for coronary artery bypass grafting (CABG) surgery;
  5. Voluntary participation and signing of the informed consent form.

Patients considered for this trial must not meet any of the following criteria:

  1. Acute viral myocarditis;
  2. Acute phase of myocardial infarction (≤ 3 months);
  3. Cardiac amyloidosis;
  4. Pericarditis;
  5. Expected to undergo heart transplantation;
  6. Suffering from a disease that restricts the motor system, making them unable to complete the 6-minute walk test;
  7. Suffering from autoimmune diseases;
  8. Estimated glomerular filtration rate (eGFR) < 35 ml/min/1.73m², or aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 100 U/L;
  9. Presence of any untreated precancerous lesions or those requiring active monitoring;
  10. Occurrence of malignant tumors within 5 years prior to screening;
  11. Expected to undergo other concurrent cardiac surgeries (excluding ventricular aneurysm resection and left atrial appendage excision/ligation);
  12. Having contraindications to the use of immunosuppressants;
  13. Having contraindications to MRI;
  14. Having contraindications to CABG surgery;
  15. Females who are pregnant, lactating, or have a positive blood pregnancy test;
  16. Plans to conceive within one year;
  17. Having systemic diseases that are not effectively controlled;
  18. Other conditions deemed unsuitable for participation in this clinical trial as evaluated by the investigator.
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